Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers

Tiziana Life Sciences

Status and phase: Completed; Phase 1

Conditions: Tolerability; Safety

Treatments: Drug: Placebo; Drug: Foralumab Nasal

Study type: Interventional

Funder types: Industry

Identifiers

NCT06879067

134155

Details and patient eligibility

About

The goal is to establish the safety of administration of nasal foralumab to healthy volunteers in escalating doses to determine the dose at which immune effects are observed. Patients will receive doses for 5 consecutive days and have a follow-up period.

Full description

This was a randomized, double blind phase 1 dose escalation study evaluating 3 dose levels of foralumab via intranasal administration from single-dose vials. The rationale behind the proposed research was to establish an immunologically active dose of foralumab given by the nasal route. Given that foralumab has never been administered by the nasal route to humans, this was a safety and dose finding study. Each dose group was observed until Day 7 to assess safety before moving to the next higher dose. This study also helped determine the dose at which immune effects (induction of regulatory T cells and changes in cytokine profiles of immune cells) were observed in subjects treated with foralumab.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men or women ages 18 to 65 years
• Healthy adults
• Ability and willingness to provide informed consent and comply with study requirements and procedures

Exclusion criteria

• Chronic medical disease compromising organ function
• Corticosteroids within the past month
• Pregnancy or lactating
• Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, thyroid disease, or type I diabetes
• Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past year.
• Participation in another clinical trial within the past 30 days
• Known history of drug or ETOH abuse
• Screening labs outside of the normal range; EBV IgM positive subjects with clinical signs will not receive study drug
• Nasal corticosteroids; antihistamines; nasal flu dosing within 30 days

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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27 participants in 4 patient groups, including a placebo group

nasal foralumab 10 μg daily

Experimental group

Description:

Group A: nasal foralumab 10 μg daily for 5 days

Treatment:

Drug: Foralumab Nasal

nasal foralumab 50 μg daily

Experimental group

Description:

Group B: nasal foralumab 50 μg daily for 5 days

Treatment:

Drug: Foralumab Nasal

nasal foralumab 250 μg daily

Experimental group

Description:

Group C: nasal foralumab 250 μg daily for 5 days

Treatment:

Drug: Foralumab Nasal

placebo

Placebo Comparator group

Description:

The placebo was acetate buffer. It was handled in a manner identical to active drug.

Treatment:

Drug: Placebo